NPR Affiliate Airs Dietary Supplement Discussion

Weight-loss supplements have been drawing media and regulatory attention for years. Recently, WAMU-FM, a Washington D.C.-area National Public Radio (NPR) affiliate, featured a discussion of dietary supplement regulation and quality, with a healthy lean towards issues in the weight-loss category, including recent FDA findings of adulteration with pharmaceutical ingredients.

On Feb 17., the Kojo Nnamdi Show, which is locally produced in Washington, welcomed Arthur Frank, M.D., medical director of the George Washington University Weight Management Program, and Sandra Kweder, deputy director of the FDA's Office of New Drugs.

The pair talked with Nnmadi about various considerations in taking over-the-counter (OTC) diet pills, and Kweder added info about FDA's work in calling out manufacturers of weight-loss dietary supplements that the agency found are adulterated with pharmaceutical drug ingredients. She said FDA maintains an online list of products found to be so adulterated—currently 69 products are indicated—and added only a few of these products have been voluntarily recalled as requested by FDA.

Kweder hit a sore spot during the discussion of issues with supplement regulation, saying unlike the regulations for drugs there are only "voluntary" good manufacturing practices (GMPs) for dietary supplements. Later in the program, Nnamdi took calls from listeners, including "Gretchen" from Springfield, Va., who called out Kweder on her misinformation about supplement GMPs. The caller informed tha FDA finalized mandatory GMPs that have already become effective for large companies. Kweder responded most of the products in question aren't from large companies. The caller then said the medium and smaller companies will also have to comply with the GMPs.

Dr. Frank argued doctors like himself face issues when advising patients to take a nutrient or herb, because supplements are not tested for effectiveness or purity; they don't undergo clinical trials; there is no knowledge of the active ingredient in the botanical; there is no info on the product's potency or what dose consumers should take; and side effects have not being studied. He asked why anyone would take a pill that is not studied or tested, adding that this is what people do when they go into GNC and buy a bottle of pills they think will solve their problem.

Kweder then backtracked, saying hopefully the GMPs will prevent supplement products from being tainted. She added GMPs will not sovle problems with safety and effectiveness.

However, Kweder seemed to shine a moer positive light on Alli, the non-prescription drug, lower-dose version of Xenical. She said her agency requires clinical studies on such lower-dose OTC products to support their weight-loss claim, adding the company must also show the product is reasonably safe in an OTC setting. She also said it is important when allowing a drug to go OTC as a lower dose that the company does "actual studies" and that the average consumer is able to understand the directions of use.

You can listen to the program here (there is a fundraising bit in the beginning).